Zilver PTX recallZ-1275-2013 · Cook, Inc. · initiated Apr 18, 2013

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Cook, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner catheter after stent deployment, and separation of the inner catheter tip section (13 complaints with an occurrence rate of 0.043%) Two adverse events, including one death, occurred in cases where a tip separation

FDA root cause category: Process control

What the company is doing

Cook Medical sent an Urgent Medical Device Recall letter dated April 24, 2013 to all affect customers. The letter identified the affected products, description of the problem, and actions to be taken. The letter instructed customers to stop use, quarantine, and return all affected products. Customers were asked to complete product reply form and return affected products for credit to Cook Medical, ATTN: Retrun Goods/RGA # 2013C0003. For questions contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Recall details

Recall number: Z-1275-2013
Status: Terminated
Initiated by the company: Apr 18, 2013
Posted by the FDA: May 15, 2013
Recalling firm: Cook, Inc.
Quantity: 535 units in USA
Product code: NIU
FDA submissions: P100022
Distribution: Worldwide Distribution - USA Nationwide; in the countries of Japan, Europe, Brazil, and Australia

Product description

Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an artery in the thigh (femoropopliteal artery). The Paclitaxel coating helps prevent the artery from narrowing again (restenosis). The Zilver; PTX stent acts as a scaffold to: Hold open a narrowed artery in the thigh (femoropopliteal artery) caused by PAD. Improve blood flow to the extremity.

Code information (models, lots, serial numbers)

REF ZIV6-35-125-7-80-PTX ; UDI 10827002248950 all lots distributed through 4/16/13

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Zilver PTX G24895
Cook Ireland Ltd · Stent, superficial femoral artery, drug-eluting
1 recall3 reports

Product lines

Zilver PTXCook Ireland Ltd · 28 models · 302 reports · 2 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 64975).

Z-1274-2013 · Terminated
Zilver PTX Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tub…

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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